Raylene’s Goal

Raylene Hollrah was diagnosed with BIA-ALCL and was distraught over the fact that not even a memorandum or information document was made available to her. One of her goals in life is to make this kind of information mandatory for women seeking to have breast augmentation and a notification to women with breast implants for reconstruction after a mastectomy.

FDA announcements:

Allergan Recalls Natrelle Biocell Textured Breast Implants Due to Risk of BIA-ALCL Cancer The FDA has identified this as a Class I recall, the most serious type of recall.  Use of these devices may cause serious injuries or death. (September 12, 2019)

FDA takes action to protect patients from risk of certain textured breast implants; requests Allergan voluntarily recall certain breast implants and tissue expanders from market  (July 24, 2019)

Statement from FDA Principal Deputy Commissioner Amy Abernethy, M.D., Ph.D., and Jeff Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health on FDA’s new efforts to protect women’s health and help to ensure the safety of breast implants  (May 2, 2019)

Letter to Health Care Providers (February 6, 2019)

Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL) (August 2018)

Anaplastic Large Cell Lymphoma (ALCL) In Women with Breast Implants: Preliminary FDA Findings and Analyses (January 2011)